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A randomized crossover clinical trial regarding the blockage of the mineralocorticoid receptor using Eplerenone on the evolution of arterial stiffness in kidney patients one year after transplant: EVATRAN (The effect of Eplerenone on the evolution of Vasculopathy in renal transplant patients).

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513808-34-00
Acronym
CPRC2018/EVATRAN
Enrollment
36
Registered
2024-08-07
Start date
2021-10-12
Completion date
2025-10-14
Last updated
2025-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

kidney transplantation

Brief summary

Evolution of pulse wave velocity (PWV in m/s) adjusted to the blood pressure measured by Sphygmocor®, after 6 months of treatment with eplerenone

Detailed description

Evolution after 6 months of treatment of central Systolic Blood Pressure (CSPc), Central Diastolic Blood Pressure (CDAb), Central Pulsed Pressure (CPp), Index of Increase (Aix in %), measured by Sphygmocor® (Atcor medical) applanation tonometry, Evolution after six months of treatment of Peripheral systolic blood pressure (PASp in mmHg), peripheral diastolic blood pressure (PADp in mmHg), peripheral pulse pressure (PPp in mmHg), Evolution after six months of treatment of intima-media thickness (in mm) measured by Echotracking (ART.LAB, ESAOTE®), Evolution after six months of treatment of left ventricular mass (LVM in g/m2) measured by cardiac ultrasound, Evolution after 6 months of treatment of biological markers of oxidative stress (plasma Isoprostane and Malondialdehyde (MDA)), Evolution after 6 months of treatment of biological markers of endothelial dysfunction (endothelin, soluble endothelium selectin (sE-selectin), von Willebrand factor ), Graft function measured by blood creatinine (in micromol/L) with estimation of glomerular filtration rate (DFGe in mL/min/1.73m2 ) according to the CKD-EPI formula as well asproteinuria measured by the ratio proteinuria/creatininuria (in mg/g). The percentage of patients with DFG ≥ 90, 60-89, 45-59, 30-44, 15-29, <15ml/min/1.73m2 will also be evaluated, as well as the percentage of patients with ratio proteinuria/creatininuria <500; 500-1000, 1000-2000, 2000-3000, >3000 at 6 months, Occurrence of hyperkalemia ≥ 5.5 mmol/L and the number of hyperkalemias during hyperkalemia follow-up between 5 - 5.49; 5.5 - 6; >6mmol/L, Risk of acute renal failure defined as an increase in creatinine of more than 50%.

Interventions

DRUGINSPRA 25 mg
DRUGcomprimé pelliculé

Sponsors

CHRU De Nancy
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Evolution of pulse wave velocity (PWV in m/s) adjusted to the blood pressure measured by Sphygmocor®, after 6 months of treatment with eplerenone

Secondary

MeasureTime frame
Evolution after 6 months of treatment of central Systolic Blood Pressure (CSPc), Central Diastolic Blood Pressure (CDAb), Central Pulsed Pressure (CPp), Index of Increase (Aix in %), measured by Sphygmocor® (Atcor medical) applanation tonometry, Evolution after six months of treatment of Peripheral systolic blood pressure (PASp in mmHg), peripheral diastolic blood pressure (PADp in mmHg), peripheral pulse pressure (PPp in mmHg), Evolution after six months of treatment of intima-media thickness (in mm) measured by Echotracking (ART.LAB, ESAOTE®), Evolution after six months of treatment of left ventricular mass (LVM in g/m2) measured by cardiac ultrasound, Evolution after 6 months of treatment of biological markers of oxidative stress (plasma Isoprostane and Malondialdehyde (MDA)), Evolution after 6 months of treatment of biological markers of endothelial dysfunction (endothelin, soluble endothelium selectin (sE-selectin), von Willebrand factor ), Graft function measured by blood creatin

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026